Individual Funding Requests (IFR) Document Version Control Version 0.1 Draft Pilot version 1 st draft version replacing 'Low Clinical Priority and Requests for Treatment Policy'. Version 2.0 Ratified Replaces Low Clinical Priority and Requests for Treatment Policy Version Version 14/07/09 7/09/09 1
Document Management Title of document Type of document Description Target audience Author Department Directorate Approved by Individual Funding Requests Policy NHS Northamptonshire is required to have a process for considering funding for individuals who seek NHS commissioned services outside established commissioning policies. All staff East Midlands Specialised Commissioning Group in conjunction with a legal team Individual Funding Requests (IFR) Strategy & System Management Governance Committee Date of approval 7 th September 2009 Next review date July 2010 Related documents Superseded documents Internal distribution External distribution Availability Contact details (of main contact for this document) Defining the Boundaries between NHS and Private Healthcare Low Clinical Priority and Requests for Treatment Policy March 2008 Intranet Extranet All ratified policies, strategies, procedures and protocols are published on the Trust Intranet and Public Website. Name: Tracey Harris Address: Francis Crick House Tel: 01604 651318 E-mail: tracey.harris@northants.nhs.uk
CONTENTS PAGE 1. Introduction 5 2. Purpose 6 3. NHS Northamptonshire s principles that underpin IFR decision 7 making 4. Policy Guidance 8 4.1. Introduction to new drugs and technologies 8 4.2. National Institute of Health and Clinical Excellence (NICE) 9 New Technology Appraisals 4.3. Treatments covered by NHS Northamptonshire s policies 9 4.4. Treatments not covered by NHS Northamptonshire s policies 10 4.5. Requests to continue funding for patients coming off drugs 10 trials 4.6. Requests to continue funding for treatments commenced at 11 risk by providers or by others (including patients) 4.7. Requests to continue funding of care commenced privately 12 (e.g. reverting to NHS care) 4.8. Decisions inherited from other Primary Care Trusts (e.g. 12 patients who move) 4.9. Second opinions 13 4.10. Treatment in another country 13 5. Defining exceptionality and an individual patient 13 5.1 Exceptionality 13 5.2 An individual patient 15 6. The process for managing an IFR 16 6.1 Who can submit an IFR 16 6.2 Administration and reporting 16 6.3 Timescale for managing an IFR 16 6.4 Initial handling of an IFR 17 6.5 Submission of a Treatment Request Form 17 6.6 Triage of a Treatment Request Form 18 6.7 Identifying urgent cases 19 6.8 Organisation of an IFR meeting 20 6.9 Membership of the IFR panel 21 6.10 Decision making framework of the IFR Panel 22 3
6.11 Demonstrating exceptional circumstances 23 6.12 The likely clinical outcomes of the proposed treatment 23 6.13 The costs of the proposed treatment 24 6.14 Similar patients 25 6.15 Recording the decision 25 6.16 Outcome of the IFR Panel 25 6.17 Reconsideration 26 7. Review of IFR Panel decisions 26 7.1 Grounds for requesting a review of the IFR Panel decision 26 7.2 Initial consideration of a request for a review of the IFR Panel 27 decision 7.3 Membership of the review panel 27 7.4 Purpose of the review panel 27 7.5 Outcome of the review panel 29 8. Training 29 9. Monitoring 30 10. References 30 Appendices Appendix A: Stages/suggested timelines of the IFR process for routine requests 32 Appendix B1: Flowchart of IFR process for routine cases 33 Appendix B2: Flowchart of review process for routine cases 34 Appendix C: Individual Funding Treatment Request form 35 Appendix D: Guidance notes for clinicians 40 Appendix F: Decision framework document for IFR Panel 43 Appendix G: Terms of reference of the IFR Panel 48 Appendix H: Terms of reference of the review panel 51 4
1. INTRODUCTION The NHS exists to serve the needs of all of its patients but also has a statutory duty financially to break even (National Health Service Act 2006). Primary Care Trusts (PCT) have a responsibility to provide health benefit for the whole of their population, whilst commissioning appropriate care to meet the clinical needs of individual patients. NHS Northamptonshire is a PCT and receives a fixed budget from Central Government with which to commission the healthcare required by its population. Commissioned services include those provided through primary, secondary and tertiary care NHS providers, the independent sector, voluntary agencies and independent NHS contractors and in house service providers. The mechanism through which investment and disinvestment decisions are taken is the Local Operational Plan (LOP) process. NHS Northamptonshire does not expect to make significant decisions outside this process and in particular does not expect to commit significant new resources in year to the introduction of new healthcare technologies (including drugs, surgical procedures, public health programmes) since to do so risks ad hoc decision making and can destabilise previously identified priorities. The LOP process, by its very nature, focuses on cohorts of patients with the more common clinical conditions. It cannot meet every healthcare need of all patients in any one clinical group or address the specific needs of patients with less common clinical conditions. The fact that NHS Northamptonshire is not meeting a healthcare need due to resource constraints is an inevitable fact of life in the NHS and does not indicate that NHS Northamptonshire is breaching its statutory obligations. NHS Northamptonshire is required to have a process for considering funding for individuals who seek NHS commissioned services outside established commissioning policies. There are in general two types of requests that come before an Individual Funding Request Panel (the IFR Panel), namely: 1. Requests for funding for treatments for medical conditions where NHS Northamptonshire has no established commissioning policy (as shown by NHS Northamptonshire policy or the treatments which are approved for routine funding in service agreements). 2. Requests for funding for treatments for medical conditions where NHS Northamptonshire does have an established commissioning policy for that condition but where the requested individual treatment is not in 5
NHS Northamptonshire policy or does not meet the criteria set out in the policy. This policy requires requests in the first category to be considered against the tests of clinical effectiveness, cost effectiveness and affordability provided the patient is able to demonstrate that they represent an Individual Patient (as defined in this policy). For patients in the second category the policy requires, as a threshold condition, patients to demonstrate that they have exceptional clinical circumstances. If the patient is able to demonstrate exceptional clinical circumstances (as defined in this policy) the request will be considered against the tests of clinical effectiveness, cost effectiveness and affordability. This approach ensures that decisions relating to resource allocation are made transparently and consistently in relation to treatment for those patients with rare conditions, those patients for whom treatments of uncertain or unproven medical benefit are sought, or where treatment costs requested may be out of proportion with the benefit to the patient. NHS Northamptonshire is responsible for the management of IFR. This policy must be used to consider: requests for any form of medical treatment or care which is not included within existing service agreements; requests for any form of medical treatment or care which, for this particular patient, are outside the parameters set by existing service agreements; requests for any form of medical treatment or care where the treatment or care proposed could not be considered to be mainstream. NHS Northamptonshire has established an IFR process to consider such applications. This may include consideration by the IFR Panel. In considering an individual case the IFR Panel will apply NHS Northamptonshire Commissioning Principles for decision making set out in Section 3 and the underpinning policies of NHS Northamptonshire. 2. PURPOSE The IFR process set out in this policy will be used to consider individual requests for funding where a service, intervention or treatment falls outside existing service agreements. 6
This process will ensure that each request for individual funding is considered in a fair and transparent way, with decisions based on the best available evidence and in accordance with NHS Northamptonshire commissioning principles. 3. NHS NORTHAMPTONSHIRE COMMISSIONING PRINCIPLES THAT UNDERPIN IFR DECISION MAKING It is important that NHS Northamptonshire ensures a consistent approach is used to guide the allocation of its resources in both population based and individual commissioning decisions. A principle 1 based decision making process supports the strategic planning and the effective use of resources within NHS Northamptonshire. All NHS Northamptonshire commissioning decisions need to be made in accordance with these principles. The Principles that NHS Northamptonshire seeks to support are: NHS Northamptonshire requires clear evidence of clinical effectiveness before NHS resources are invested in the treatment NHS Northamptonshire requires clear evidence of cost effectiveness before NHS resources are invested in the treatment the cost of the treatment for this patient and others within any anticipated cohort is a relevant factor. NHS Northamptonshire will consider the extent to which the individual or patient group will gain a benefit from the treatment NHS Northamptonshire will balance the needs of each individual against the benefit which could be gained by alternative investment possibilities to meet the needs of the community NHS Northamptonshire will consider all relevant national standards and take into account all proper and authoritative guidance Where a treatment is approved, NHS Northamptonshire will respect patient choice as to where a treatment is delivered. When considering an IFR, NHS Northamptonshire will also ensure that decisions: 1 principle: a basic truth or a general law or doctrine that is used as a basis of reasoning or a guide to action or behaviour 7
comply with relevant national policies or local policies and priorities that have been adopted by NHS Northamptonshire concerning specific conditions or treatments are based on the available evidence concerning the clinical and cost effectiveness of the proposed treatment, including any NICE publications and; are taken without undue delay; a pragmatic approach may need to be taken when dealing with urgent requests i.e. where a delay in reaching a decision to fund adversely affects the clinical outcome. NHS Northamptonshire considers all lives of all patients to be of equal value and in making decisions about funding treatments will seek not to discriminate on the grounds of age, sex, sexuality, race, religion, lifestyle, occupation, family and caring responsibilities, social position, financial status, family status (including responsibility for dependents), intellectual/cognitive functioning or physical functioning save where a difference in the treatment options made available to patients is directly related to the patient s clinical condition or is related to the anticipated clinical benefits for this individual to be derived from a proposed form of treatment. 4. POLICY GUIDANCE In considering individual cases, NHS Northamptonshire will apply the Commissioning Principles, the underpinning policies of NHS Northamptonshire and the following guidance which expands upon them. 4.1 Introduction of New Drugs and Technologies NHS Northamptonshire will not introduce new drugs/technologies in an ad hoc basis through the mechanism of individual case funding. To do so risks inequity, since the treatment will not be offered openly and equally to all with equal need. There is also the risk that diversion of resources in this way will de-stabilise other areas of health care which have been identified as priorities by NHS Northamptonshire. NHS Northamptonshire expects consideration of new drugs/technologies to take place within the established planning frameworks of the NHS (for example the LOP). This will enable clear prioritisation against other calls for funding and the development of implementation plans which will allow access for all patients with equal need. 4.2 NICE New Technology Appraisals 8
Drugs and technologies that are approved as the result of a NICE Technology Appraisal (NTA) need to be implemented within 3 months of the appraisal being published. NHS Northamptonshire will, within resource constraints, seek to ensure implementation of NICE NTA s without delay but recognises that NHS Northamptonshire may take the full period of 3 months before a new commissioning policy can be brought into place where significant service change and/or development are required as part of the implementation. NICE also produces clinical guidelines which are a valuable source of good practice which NHS Northamptonshire will take into account in developing policy but NHS Northamptonshire retains discretion and is not mandated by Directions to implement such Guidance within a fixed time period or at all. 4.3 Treatments Covered by NHS Northamptonshire Commissioning Policies NHS Northamptonshire s policy is that treatments not currently included in established care pathways (as identified, for example, in the Schedules to the service agreements with acute care provides) or identified for funding through the LOP process are not routinely funded. For a number of these interventions NHS Northamptonshire have published specific policy statements setting out restrictions on access based on evidence of effectiveness or relative priority for funding. Appendix I. Policy development is an ongoing process and future policy on further treatments, in response to NICE Guidance/Guidelines, health technology assessments etc will be produced and published. The East Midlands Specialised Commissioning Team is developing a range of collaborative commissioning policies on behalf of all East Midlands PCT s. Once developed, these will be considered by the East Midlands Specialised Commissioning Board. Once approved, the policy of NHS Northamptonshire is that it is minded to adopt the commissioning policies of the East Midlands Specialised Commissioning Board to ensure coherence with neighbouring PCT s and to minimise exposure to claims of postcode healthcare. However NHS Northamptonshire reserves the right to take a decision not to adopt a policy proposed by the East Midlands Specialised Commissioning Board. 9
4.4 Treatments Not Covered by PCT Commissioning Policies Specific groups of patients may not be covered by NHS Northamptonshire Commissioning Policy including: Patients with conditions for which NHS Northamptonshire does not have an agreed policy, including patients with rare conditions and whose proposed treatment is outside agreed service agreements Patients with conditions for which NHS Northamptonshire does have an agreed policy but who may have exceptional clinical circumstances which lead to their clinician seeking a treatment that is not routinely available. In such circumstances NHS Northamptonshire will not have given approval in advance to fund the treatment and approval will therefore be required under this policy. The treating clinician should consider, before making the application, whether the requested treatment is an appropriate request judged against NHS Northamptonshire s Commissioning Principles. The role of the IFR Panel is to make decisions on individual cases. It cannot be used as a means of creeping implementation for new technologies. Consideration therefore needs to be given as to the likelihood of other patients having the same clinical need who could also benefit from the proposed treatment. If there are or are likely to be other patients then, properly considered, the request is for a service development and not an individual application. Where a decision may affect other patients, the application should be considered as a service development and not through the IFR process. Patients with rare conditions should neither be advantaged nor disadvantaged simply because their condition is uncommon. This means that the same approach will be taken in applying the principles of clinical effectiveness and cost effectiveness to patients with rare conditions as should be applied to all other patients. 4.5 Requests to Continue Funding for Patients Coming Off Drugs Trials NHS Northamptonshire does not expect to provide funding for patients to continue medication/treatment commenced as part of a clinical trial. In line with the Medicines for Human Use (Clinical Trials) Regulations 2004 and the Declaration of Helsinki, the responsibility lies with those conducting the trial to ensure a clear exit strategy from a 10
trial AND that those benefiting from treatments provided within the trial setting will have ongoing access to those treatments. The initiators of the trial (provider trusts and drug companies) have a moral obligation to continue funding patients benefiting from treatment until such time as NHS Northamptonshire agrees to fund through the LOP process. Where the treatment is not prioritised through the LOP, the responsibility remains with the trial initiators. The Research Ethics Committee should require this assurance as part of the approval for the trial. 4.6 Requests to Continue Funding for Treatments Commenced at risk by Providers or by Others (Including Patients) On occasions, a request is received where a provider trust has commenced an unfunded treatment prior to asking for or receiving confirmation that NHS Northamptonshire will approve funding. Evidence that the patient is responding to the treatment is then presented as part of the case for NHS Northamptonshire funding. The provider trust s decision to commence treatment in advance of any decision by NHS Northamptonshire to fund is a clear risk taken by the trust and/or patient. NHS Northamptonshire accepts no responsibility for the decision taken by the provider trust in these circumstances. In considering a request for funding NHS Northamptonshire will apply the criteria set out in this policy as it would for any other request, and accords no special privileges because the unfunded drug was given by a provider trust. NHS Northamptonshire s policy is that, unless a decision has been taken to approve routine funding for a treatment, the treatment will only be commissioned for an individual patient if the patient is able to demonstrate exceptional clinical circumstances. The fact that a patient has responded to drug or other treatment in a manner which was anticipated for a proportion of patients who are commenced on the treatment is unlikely to be sufficient to demonstrate exceptional clinical circumstances. Where such an application is approved on the basis that the patient has demonstrated exceptional clinical circumstances, NHS Northamptonshire will not accept responsibility for the costs of any treatment provided by the provider trust prior to authorisation being given by NHS Northamptonshire. 11
A similar approach will be adopted if a treatment has been funded initially by a pharmaceutical company or other third party. There are occasions where the initial stages of an unfunded treatment have been funded privately by the patient. NHS Northamptonshire will consider any information submitted on behalf of a patient in support of their case that the patient has exceptional clinical circumstances. This may include evidence derived from treatment that has been purchased privately and used by the patient. However, this potentially opens the way for a limited group of patients who can afford to fund a treatment that NHS Northamptonshire does not usually fund to be able to demonstrate benefit by virtue of access to private care and then submit this as a reason to justify NHS funding for the treatment in their particular case. This is a potentially inequitable approach and, in order to ensure that NHS Northamptonshire does not act in an inequitable manner, the issue of exceptional clinical circumstances will therefore continue to be the criteria applied by the IFR process. Accordingly, NHS Northamptonshire adopts no presumption in favour of continuing treatment which has been previously paid for privately by the patient. As stated above, evidence that a treatment works as anticipated for a proportion of patients in the patient s clinical circumstances is unlikely, in itself, to provide evidence of exceptionality. 4.7 Requests to Continue Funding of Care Commenced Privately e.g. reverting to NHS care Patients who are having private treatment have a right to revert to NHS funded treatment at any point during their care. However, if they wish to exercise this right, NHS Northamptonshire will expect their care to be transferred to local pathways. Funding for the individual to continue care in a private facility or to transfer to an NHS provider with which a clinician consulted privately has a contract of employment will not routinely be authorised unless they form part of local pathways. Where personal clinical circumstances may make such funding appropriate the case will require consideration by the IFR process. 4.8 Decisions Inherited from Other Primary Care Trusts e.g. patients who move Occasionally patients move into the area and become the responsibility of the PCT (by registering with an NHS Northamptonshire GP) when a package of care or 12
treatment option has already been approved by the PCT that was previously responsible for the patient s care. The PCT s policy is that, subject to resource constraints, it will normally agree to continue the treatment providing the care pathway has been initiated by a responsible NHS consultant and the requested treatment remains clinically appropriate. 4.9 Second opinions Patients are entitled to request a second consultant opinion but this must be within an NHS funded clinic. Third or fourth opinions for the same clinical condition will not normally be supported unless there are extenuating circumstances. 4.10 Treatment in another country Requests for treatment in another country will only be considered if in accordance with arrangements as set out by the Department of Health (E112 form and Article 49). In all cases, prior approval from the PCT is required. 5. DEFINING EXCEPTIONALITY AND AN INDIVIDUAL PATIENT 5.1 Exceptionality The words exceptional, "exceptionality" and exceptional clinical circumstances bear their natural meanings as defined in Oxford English Dictionary. However NHS Northamptonshire recognises that the meaning of these words has given rise to considerable difficulty in the past and offers the following guidance to assist the IFR Panel and clinicians as to how to approach the meaning of the words. There is a difference between individual and exceptional. Every patient has features of his or her condition which are specific to that individual and are not likely to be repeated in other patients with the same clinical condition at the same stage of progression of the condition. Exceptionality is not the same as individuality. In order to be able to consider whether a patient has exceptional clinical circumstances the IFR Panel may find it helpful to focus on the following issues: 1. Are there any clinical features of the patient s case which make the patient 13
significantly different to the general population of patients with the condition in question at the same stage of progression of the condition? 2. Would the patient be likely to gain significantly more clinical benefit from the requested intervention than might be normally expected for the general population of patients with the condition at the same stage of the progression of the condition? The implications of this approach are that if a patient can be seen to be part of a group of patients for whom a treatment is not made available by NHS Northamptonshire under NHS Northamptonshire s existing policies then exceptionality for this individual patient is unlikely to be demonstrable. In this case the appropriate process for obtaining funding for the requested treatment will be for NHS Northamptonshire to change its policy. Such a change must happen through the LOP process (which will require the development of a business case and for the treatment to be prioritised against other developments) or through NHS Northamptonshire agreeing to make a change to its policy outside the LOP process. Once the change is made it will apply to all similar patients. However the IFR Process is not the procedure for NHS Northamptonshire to make such policy changes. NHS Northamptonshire is required to achieve financial balance each year and therefore has a default policy of not funding a treatment where no specific policy exists to approve funding for the treatment. If NHS Northamptonshire has not previously been asked to fund an intervention that has the potential to affect a number of patients, the application should be made by clinicians for NHS Northamptonshire to consider the intervention through its general commissioning policy and not by way of an IFR application. NHS Northamptonshire s policy is that the IFR committee should consider requests for treatments that are not routinely available based on the patient s clinical circumstances. This means that social and personal factors such as age, gender, caring responsibilities and family circumstances can only be taken into account where they are relevant to the patient s clinical outcome. Whilst a patient's professional, economic or social standing or their family responsibilities are important to individuals, NHS Northamptonshire s policy is that they are not relevant in assessing whether a patient has exceptional clinical circumstances. 14
5.2 An Individual Patient For the purposes of this policy, an Individual Patient is determined by reviewing the incidence and prevalence of the requested intervention for a particular condition at the same stage of progression of that condition. If NHS Northamptonshire has no policy for the intervention being requested for a particular condition, then the IFR Panel can only consider the request if both the incidence and prevalence criteria that are set out below are met. In some cases, NHS Northamptonshire may have adopted policies for small numbers of patients which have often been developed regionally. If the request is covered by such a policy then it should be viewed as a request to change the policy and therefore will not be considered by the IFR policy, even if the incidence and prevalence criteria are met. An IFR request will be considered by the IFR Panel on its individual merits with the decision on whether to fund a requested intervention based on the evidence of clinical and cost effectiveness and affordability. If both the prevalence and incidence criteria are not met then NHS Northamptonshire will not consider that the request represents an individual patient. In these circumstances, funding can only be provided if a decision is made by NHS Northamptonshire to develop a policy for the requested intervention for a group of patients, including the requesting patient. Such a change must happen through the LOP process (which will require the development of a business case and for the treatment to be prioritised against other developments) or through NHS Northamptonshire agreeing to develop a policy outside the LOP process. Once the policy is developed it will apply to all similar patients. However, the IFR Process is not the procedure for NHS Northamptonshire to develop such policy. Incidence e.g. the number of new cases of a disease in a defined population within a specified period of time The intervention for a particular condition at the same stage of progression of that condition is expected to be initiated for two or fewer patients per million population per year (10 patients across the East Midlands SHA PCT s population per year). Prevalence e.g. the number of cases of a disease in a defined population at a point in time The total number of patients on the intervention for a particular condition at the same stage of progression of that condition is less than 10 patients per million population at 15
any one time (40 patients across the East Midlands SHA PCT population) 6. THE PROCESS FOR MANAGING INDIVIDUAL FUNDING REQUEST (IFR) 6.1 Who can submit an IFR This policy will apply to any patient for whom NHS Northamptonshire is the responsible commissioner. A doctor, or other health care professional directly involved in the care of a patient, can make a request for an intervention not routinely funded (as defined in Section 2.). A patient, or a non-clinical representative, may not submit an IFR as a clinical sponsor is required. On receipt of a submission the following IFR process should be followed. The IFR process is described in the table in Appendix A. and diagrammatically in the flowchart in Appendix B. 6.2 Administration and Reporting Requests will be date stamped, processed and logged onto NHS Northamptonshire s IFR database by the responsible IFR Officer (normally a Commissioning Manager). Acknowledgement will be sent to the referrer within 3 working days, with a copy to the patient/carer or guardian. It will be the responsibility of the IFR Officer to manage all requests received and correspondence with the referrer and patient/carer or guardian. The IFR Officer will normally be a member of NHS Northamptonshire s Commissioning Team. For each request received, a unique numbered case file will be generated with all paperwork pertinent to the case kept in chronological order. All decisions will be fully documented and all communication will be in writing whenever possible. When telephone conversations take place, a file note will be added as a record of the conversation. Both the evidence considered and the decision made will be recorded in writing. All national and local NHS policies regarding confidentiality, retention and destruction of records will be adhered to. The case files will be regularly reviewed by the IFR Panel and an annual report of cases considered by the IFR Panel and Review Panel will be submitted to NHS Northamptonshire s Board. 6.3 Timescale for Managing an IFR Requests will be managed within a maximum period of 40 working days from the date of the receipt of a Treatment Request Form to the date of the letter from NHS Northamptonshire informing the requesting clinician of the decision of the IFR Panel. 16
Within this time period, a number of recommended maximum time periods for stages of the IFR process are set out in Appendix A, but these are advisory, rather than mandatory, providing the overall process is completed within the 40 day period. 6.4 Initial Handling of an IFR Cases are initially dealt with, and screened, by the IFR Officer who will advise the referrer whether the existing portfolio of contracts, SLAs or current commissioning policies would cover the request. If a policy exists, and where appropriate, the IFR Officer will check whether the criteria within the policy can be applied. Where clinical advice is required, the IFR Officer will seek advice from the Public Health Directorate. Clinically urgent requests will be determined by a senior Public Health professional, nominated by the Director of Public Health, and will be managed under 6.7 Identifying Urgent Cases. If an individual meets the criteria within a policy, and a decision to agree funding can be made at this point by the IFR Officer, then a response will normally be sent to the referrer within 5 working days of the date of acknowledgement of the initial request by NHS Northamptonshire. The IFR Officer is unable to authorise referrals outside existing contractual arrangements. If the IFR Officer has reason to consider that simple application of SLAs and/or current commissioning policies would be inappropriate for a case, then the IFR Officer should advise the referrer, and the patient/guardian or carer, normally within 5 working days, that an Individual Funding Request must be submitted to the IFR Officer at NHS Northamptonshire using the IFR Treatment Request Form (Appendix C). A copy of the Guidance Notes for submission of a Treatment Request Form should be included (Appendix D). If a clinician wishes to discuss whether submission of a Treatment Request Form is appropriate, or would like help with completing the Treatment Request Form, then they should contact NHS Northamptonshire s Public Health Directorate. 6.5 Submission of a Treatment Request Form Only a member of the clinical team who are currently directly involved in the clinical care of the patient (usually their Consultant or GP) can submit a Treatment Request Form. On receipt of a Treatment Request Form, NHS Northamptonshire s IFR Officer will acknowledge receipt within 3 working days using a standard letter outlining NHS Northamptonshire s IFR process. The patient s GP will be sent a copy of all 17
correspondence regarding the case if they are not the requesting clinician. 6.6 Triage of a Treatment Request Form The Treatment Request Form will be triaged by the IFR Officer and a senior Public Health professional, nominated by the Director of Public Health (the Screening Pair). The skills and expertise required of the screening pair are the ability to: Determine whether an existing policy or SLA adequately covers the treatment request Interpret NHS Northamptonshire s definitions of exceptionality and an individual patient in the context of the clinical information that is presented The pair will be able to consider three options; Approve the request if covered by an existing SLA/ commissioning policy Refuse the request without reference to the IFR Panel Refer to the IFR Panel The criteria that are used to triage a Treatment Request Form is whether there is an arguable case, based on the evidence presented in the application, that the IFR Panel will approve funding for the requested treatment under this policy. The application will be refused at the triaging stage if: 1. the requested treatment arises in relation to a medical condition where there is NHS Northamptonshire policy and (a) the requested treatment is not a treatment that is approved under the policy, and (b) there is no arguable case on the evidence presented that the patient can show exceptional clinical circumstances. 2. the requested treatment arises in relation to a medical condition where there is no NHS Northamptonshire policy and on the evidence presented the requested intervention for that particular condition may affect other patients in NHS Northamptonshire s population as defined in this policy under 5.2. so that the request should be properly treated as a request to change NHS Northamptonshire policy. Where there is uncertainty, the case should be referred to the IFR Panel. All 18
decisions made by the Screening Pair will be recorded and reported to the IFR Panel on a quarterly basis. A routine request will normally be triaged with 10 working days of the date of receipt of the Treatment Request Form by NHS Northamptonshire unless additional information is required when an additional 10 working days will be granted. The requesting clinician will be contacted by letter and asked to comment on the whether any additional information should be included in the Treatment Request Form. If a request is refused a letter will be sent to the clinician and the patient explaining the reasons for the decision and outlining the options that are available, including using the NHS Complaints Procedure. If a request is refused at the triaging stage this policy does not provide a right of appeal to the IFR Committee and does not provide a right to request that the decision should be reviewed by the Review Committee. However the patient has a right to make a complaint under the NHS Complaints Procedure. One outcome of such a complaint could be to require the triaging process to be reconsidered or for the case to be referred to the IFR Panel for consideration. If a request is referred for consideration by the IFR panel a meeting will normally be convened within 20 working days of the date of the triage meeting. 6.7 Identifying Urgent Cases A senior Public Health professional, nominated by the Director of Public Health, can determine that a case is clinically urgent at any point in the IFR process after consultation with the patient s clinicians. The timing of an urgent IFR Panel will be based on the individual clinical circumstances and the risks of an adverse clinical outcome if a funding decision on treatment is delayed. An extraordinary IFR meeting can be convened of a senior Public Health professional, nominated by the Director of Public Health, and a Clinical Member of the Professional Executive Committee, or equivalent, as a minimum membership, with other panel members attending, if available, in order to reach an immediate decision. Ideally all urgent cases will be considered by a face-to-face meeting, but exceptionally, where the clinical need makes this impossible, communication via phone or e-mail will be deemed appropriate. Decisions that are made urgently 19
outside of a formal IFR Panel meeting will be taken for ratification to the next meeting of the IFR Panel. Where an urgent request is required to be considered, the IFR Panel shall continue to follow the procedure set out in this policy. In particular if a request, even if urgent, may affect other patients with the condition in question at the same stage of progression of the condition, and thus is inappropriate for an IFR request, it shall be refused. Where, in order for NHS Northamptonshire to be able lawfully to commission the requested treatment, NHS Northamptonshire is required to change its commissioning policy, this can only happen if the clinician and/or the patient request NHS Northamptonshire to make an in-year change to its commissioning policy. Such an application must be made outside the IFR policy. 6.8 Organisation of an IFR Meeting The IFR Officer will arrange the date of the meeting and contact the requesting clinician to ask if they wish to submit any further information. The IFR Officer will write to the patient/carer or guardian to inform them of the date set for consideration by the IFR Panel, to list the items of information that will be presented to the IFR Panel, and to ask them if they wish to provide written information to the IFR Panel. This might include: information on how their condition affects their quality of life; their understanding of the evidence base and how this might apply to them; information from friends or family; information from clinicians or patient support groups, etc. However, the IFR Officer should remind the patient that decisions can only be made on the grounds of the patient s clinical circumstances and not on the basis of the patient s social or personal circumstances. The patient/carer or guardian, or their clinical or non-clinical representative, are not entitled to attend the IFR Panel in person. The IFR Officer may also write to other health professionals with clinical involvement in the patient s care (for example consultant, therapist etc), or to others with specialist knowledge with regard to the condition/intervention, for clarification of the patient s needs, evidence base etc, if appropriate. The IFR Officer, with support from Public Health and Medicines Management, will 20
produce a summary of the case using the Decision Framework Document (Appendix F) which will be considered by the IFR Panel. All the documentation that has been received regarding the request will also be made available to the IFR Panel but in an anonymised form to protect confidentiality. 6.9 Membership of the IFR Panel NHS Northamptonshire will have an IFR Panel (Terms of Reference Appendix G). The IFR Panel will consider all cases referred to it by the Screening Tier. Members of the IFR Panel should together have the skills and expertise necessary to make effective, fair and rationale decisions by considering the evidence in the Decision Framework Document. The key competencies and experience required within a Panel are: Ability to understand and interpret the clinical information regarding the individual case and place it in the context of a wider clinical population Ability to understand and interpret clinical and cost effectiveness data (critical appraisal skills) A lay/societal perspective Ability to understand and advise on the broader commissioning policy implications for NHS Northamptonshire including consideration of the intervention in the LOP process The core panel will consist of: Director of Public Health or nominated deputy Executive Director or nominated deputy Clinical Member of the Professional Executive Committee (PEC)/ Clinical Cabinet or equivalent Non-Executive Director/ NHS Northamptonshire lay representative Other individuals with specific expertise and skills may also be included on the IFR Panel e.g. pharmacist, commissioning manager in order to ensure effective and robust decision making. The IFR Panel members will determine who is to chair the IFR Panel. The IFR Panel will only be quorate if three of the core members are present, including the Director of 21
Public Health (or nominated deputy) and the Clinical Member of the Professional Executive Committee (PEC)/ Clinical Cabinet (or equivalent). The IFR Officer will present the case to the members of the IFR Panel. Decisions will be reached by consensus where possible, but if a consensus cannot be achieved, will be decided by a vote of the IFR Panel members. If the IFR Panel is equally split then the chair will have a casting vote. Clinical members of the PEC who have had any clinical involvement with an individual case can not be part of the IFR Panel hearing for that request. 6.10 Decision making framework of the IFR Panel The IFR Panel is a sub-committee of NHS Northamptonshire s Board and has delegated authority to make decisions in respect of funding for individual cases. It is not the role of the IFR Panel to make commissioning policy on behalf of NHS Northamptonshire. Consideration by the IFR Panel will always start from the overall policy position (whether or not the intervention has been prioritised through the LOP) and will seek to determine exceptionality on that basis using the definition in Section 5. The IFR Panel shall only be entitled to approve requests for funding of treatment for individual funding requests where each of the following conditions are met: a) Either (a) the patient makes an individual request for funding for treatment in connection with a presenting medical condition for which NHS Northamptonshire has no policy and where the patient has demonstrated they represent an Individual Patient (as defined in paragraph 5.2 above) or (b) the patient makes an exceptionality request for funding for treatment in connection with a medical condition for which NHS Northamptonshire has a policy and where the patient has demonstrated exceptional clinical circumstances (as defined in paragraph 5.1 above). b) There is sufficient evidence to show that, for the individual patient, the proposed treatment is likely to be clinically effective. c) Applying the approach that NHS Northamptonshire takes to the assessments of costs for other treatments outside this policy, the cost to NHS Northamptonshire of providing funding to support the requested treatment is 22
justified in the light of the benefits likely to be delivered for the individual patient by the requested treatment. 6.11 Demonstrating exceptional circumstances. a) The Clinical Team are required to present a full report to the IFR Panel using the Treatment Request Form which sets out a comprehensive and balanced clinical picture of the history and present state of the patient s medical condition, the nature of the treatment requested and the anticipated benefits of the treatment. b) The IFR Panel shall determine, based upon the evidence provided to the IFR Panel, whether the patient has demonstrated exceptional clinical circumstances. The evidence to show that, for the individual patient, the proposed treatment is likely to be clinically effective may be part of the case that the patient s clinical circumstances are asserted to be exceptional. c) In determining whether a patient is able to demonstrate exceptional circumstances the IFR Panel shall compare the patient to other patients with the same presenting medical condition at the same stage of progression. d) The IFR Panel shall take care to avoid adopting the approach described in the the rule of rescue. The fact that a patient has exhausted all NHS treatment options available for a particular condition is unlikely, of itself, to be sufficient to demonstrate exceptional circumstances. Equally, the fact that the patient is refractory to existing treatments where a recognised proportion of patients with same presenting medical condition at this stage are, to a greater or lesser extent, refractory to existing treatments is unlikely, of itself, to be sufficient to demonstrate exceptional circumstances. 6.12 The likely clinical outcomes of the proposed treatment. The Clinical Team shall: 23
a) describe the anticipated clinical outcomes for the individual patient of the proposed treatment and the degree of confidence of the Clinical Team that the outcomes will be delivered for this particular patient; b) refer to, and preferably include, copies of any clinical research material which supports, questions or undermines the case that is being made that the treatment is likely to be clinically effective in the case of the individual patient. The IFR Panel shall be entitled but not obliged to commission its own reports from any duly qualified or experienced clinician, medical scientist or other person having relevant skills concerning the case that is being made that the treatment is likely to be clinically effective in the case of the individual patient. The IFR Panel is not required to accept the views expressed by the Clinical Team concerning the likely clinical outcomes for the individual patient of the proposed treatment but is entitled to reach its own views on: a) The likely clinical outcomes for the individual patient of the proposed treatment; and b) The quality of the evidence to support that decision and/or the degree of confidence that the IFR Panel has about the likelihood of the proposed treatment delivering the proposed clinical outcomes for the individual patient. 6.13 The costs of the proposed treatment. The Clinical Team shall set out the full attributable costs of and connected to the treatment. The IFR Panel shall be entitled but not obliged to commission its own reports from any duly qualified or experienced clinician or other duly qualified person concerning the full attributable costs of and connected to the treatment. The IFR Panel shall, so far as it is able to do so, on the information before it, apply the principles set out in NHS Northamptonshire policy on cost effectiveness when reaching a view as to whether the requested treatment is likely to be cost effective. 24
In making the decision as to whether the costs of a requested treatment are justified, the IFR Panel shall refer itself to the approach concerning QALYs and ICERs that NHS Northamptonshire has adopted for other treatments and is required to bear in mind that the resources requested to support the individual patient will reduce the availability of resources for other investments. The IFR Panel shall have a broad discretion to determine whether the proposed treatment is a justifiable expenditure of NHS Northamptonshire s resources. 6.14 Similar Patients The IFR Panel shall consider whether the request is a request for a policy variation (using the definitions set out in paragraph 5.3 above). If the IFR Panel determines that the case does not refer to an Individual Patient, as defined in this policy, then it shall not be entitled to make a decision on the request but shall refer the request to be considered by NHS Northamptonshire Service Development process. This step is required because the IFR process is not designed to create precedents which may result in NHS Northamptonshire providing or being obliged to provide the same or similar treatment to other patients. Accordingly if the IFR Panel considers this is not a request about an individual patient then funding can only be provided for the requested treatment if a decision is made by NHS Northamptonshire to amend its policies to provide the treatment for a group of patients, including the requesting patient. 6.15 Recording the decision The IFR Officer will record the decision of the IFR Panel against each of the above questions on the Decision Framework Document. The completed Decision Making Framework, together with the record of attendance, will form the minutes of the meeting. The minutes will be approved by the Chair of the IFR Panel. 6.16 Outcome of the IFR Panel The IFR Officer will write on behalf of the Chair of the IFR Panel to the referring clinician, and the patient/guardian or carer, within 5 working days to inform them of the outcome of the IFR Panel meeting with the reasons for the IFR Panel decision. If funding was agreed, the IFR Officer will ensure that the clinician is able to deliver the treatment in a timely manner and that a mechanism is in place to monitor the clinical outcome in order to determine whether the treatment has resulted in benefit 25
to the patient. If funding was not agreed, the IFR Officer will inform the referring clinician, and the patient/guardian or carer, outlining the further options that are available - either reconsideration or review. 6.17 Reconsideration If the referring clinician and/or the patient/guardian or carer believes that there is further relevant information that was not considered by the IFR Panel they may ask NHS Northamptonshire to reconsider the case specifically in the light of this information. The additional information must be submitted to the IFR Officer within 10 working days of the date of the letter from NHS Northamptonshire setting out the IFR Panel decision. NHS Northamptonshire Screening Pair will determine, normally within 10 working days, whether the additional information significantly alters the nature and strength of the evidence that was submitted to the initial panel meeting. If the new information is considered to be significant, a further panel meeting will be convened within the timescales set out for the first panel. If the new information is not considered to be significant, the referring clinician and the patient/guardian or carer will be informed by letter with reasons for the decision not to refer the request back to the IFR Panel. 7. REVIEW OF IFR PANEL DECISIONS 7.1 Grounds for requesting a review of the IFR Panel Decision The referring clinician and/or the patient/guardian or carer can make a request to NHS Northamptonshire for a review of the IFR Panel s decision. The request should be made in writing to the Chief Executive of NHS Northamptonshire and must be lodged within 20 working days of the date of the letter from NHS Northamptonshire setting out the IFR Panel decision. The Chief Executive may exercise discretion in accepting requests outside this time limit if there are good reasons for the delay. The request for review must set the grounds on which the IFR Panel decision is being challenged. A review can be requested on two grounds. It is believed that: The IFR Panel failed to follow due process and, as a result, the decision 26